Eye and ENT Hospital of Fudan University , Shanghai , China.
Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.
To compare the efficacy and safety of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in a Chinese population with ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
This study was a multicenter, randomized, investigator-masked, parallel-group clinical trial. Patients aged ≥18 years with a clinical diagnosis of BKC in at least one eye received LE/T or DM/T administered 4 times daily for 2 weeks. At baseline and on days 3, 8, and 15 (visits 2, 3, and 4), clinical assessments of ocular signs and symptoms, visual acuity (VA), biomicroscopy, and intraocular pressure (IOP) were performed in both eyes.
The primary efficacy endpoint was the change from baseline (CFB) to visit 4 in the signs and symptoms composite score in designated study eyes using a non-inferiority metric to compare LE/T to DM/T. Safety evaluation included adverse events, biomicroscopy findings, and changes in VA and IOP.
NCT number, NCT01028027.
A total of 308 patients were included in the per protocol population (n = 156 LE/T, n = 152 DM/T). A significant CFB in composite signs and symptoms was seen with both treatments at each follow-up visit (p < 0.0001). The mean (SD) CFB at visit 4 was -11.63 (4.56) and -12.41 (4.71) in the LE/T and DM/T groups, respectively, and the upper bound of the 90% confidence interval for the difference was less than the prespecified non-inferiority margin. Comparable results were found for secondary efficacy outcomes. Patients treated with DM/T experienced a significantly greater increase in mean CFB in IOP compared to those treated with LE/T at all follow-up visits (p ≤ 0.0186) and nearly twice as many IOP elevations ≥5 mmHg (p = 0.0020).
Treatment with LE/T was at least as effective as DM/T in Chinese patients with BKC and had a better safety profile with respect to change in IOP.
比较 Loteprednol 乙酯 0.5%/妥布霉素 0.3%（LE/T）和地塞米松 0.1%/妥布霉素 0.3%（DM/T）滴眼混悬剂在伴有睑缘角膜结膜炎（BKC）的中国人群中治疗眼部炎症的疗效和安全性。
这是一项多中心、随机、研究者设盲、平行分组的临床试验。≥18 岁的患者，具有 BKC 的临床诊断，且至少一眼患有该病，接受 LE/T 或 DM/T 治疗，每日 4 次，共 2 周。在基线和第 3、8、15 天（访视 2、3、4），对双眼进行眼部体征和症状、视力（VA）、生物显微镜检查和眼内压（IOP）的临床评估。
使用非劣效性度量标准，比较 LE/T 和 DM/T，评估指定研究眼中从基线到访视 4 的体征和症状综合评分的变化（CFB）。安全性评估包括不良事件、生物显微镜检查结果以及 VA 和 IOP 的变化。
NCT01028027。
共有 308 例患者符合方案人群（n=156 例 LE/T，n=152 例 DM/T）。两种治疗方法在每次随访时均观察到复合体征和症状的显著 CFB（p<0.0001）。LE/T 和 DM/T 组在访视 4 时的平均（SD）CFB 分别为-11.63（4.56）和-12.41（4.71），差值的 90%置信区间上限小于预设的非劣效性边界。次要疗效结局也得到了类似的结果。与 LE/T 治疗组相比，DM/T 治疗组在所有随访时的平均 CFB 增加更显著（p≤0.0186），IOP 升高≥5mmHg 的发生率几乎高出两倍（p=0.0020）。
在患有 BKC 的中国患者中，LE/T 的治疗效果至少与 DM/T 相当，并且在 IOP 变化方面具有更好的安全性。
